Low Level Laser Therapy Versus Pharmacotherapy in in Impr... | NCT01659372

Studies
Low Level Laser Therapy Versus Pharmacotherapy in in Improving Masticatory Muscle Pain

NCT01659372

Sponsor

Shahid Beheshti University

Status

Unknown status

Last Update Posted

Aug 7, 2012Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Interventions

low level laser therapy
Naproxen

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Aug 4, 2012

First Submission Date that Met QC Criteria

Aug 6, 2012

First Posted Date

Aug 7, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2012

Last Update Posted Date

Aug 7, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

saranaz azari-marhabi, oral medicine resident, Shahid Beheshti UniversityPrincipal Investigator

Lead Sponsor

Shahid Beheshti UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

tempromandibuar disorders are a group of heterogenous pathologies affecting temporomandibular joint,muscles or both.in more than 90%of cases muscles are the origin of pain.TMDs cause pain,movement disability and deficit in quality of life.in more than 90%of cases pain is the major complaint.we run this investigation to find the analgesic effct of low level laser therapy versus pharmacotherapy with naproxen in improving pain.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low level laser therapy	Experimental	this arm recieves low level laser therapy treatment for 12 sessions.	Radiation: low level laser therapy
naproxen	Experimental	this arm takes naproxen 500 mg twice daily for 3weeks	Drug: Naproxen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low level laser therapy	Radiation		Low level laser therapy
Naproxen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduction of paim measured by VAS	VAS is visual analogue scale	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with TMD affecting masticatory muscles

Exclusion Criteria:

systemic disease
GI problem
pregnancy
epidermal cancer

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
saranaz azari marhabi, post graduate student	Contact	00989190129151		saranazazari@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shahid Beheshti University	Not yet recruiting	Tehran		1983969411	Iran
Shahid Beheshti University

Condition Browse Module

MeSH Terms

ID	Term
D013705	Temporomandibular Joint Disorders
D009209	Myofascial Pain Syndromes

Ancestor Terms

ID	Term
D017271	Craniomandibular Disorders
D008336	Mandibular Diseases
D007571	Jaw Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D028022	Low-Level Light Therapy
D009288	Naproxen

Ancestor Terms

ID	Term
D053685	Laser Therapy
D013812	Therapeutics
D010789	Phototherapy
D009280	Naphthaleneacetic Acids

Browse Leaves

Not provided

Browse Branches

Not provided